Trial Information

A Phase I Multicenter, Open Label, Clinical Trial of Immune Response, Safety and Tolerability of DNA Vector pPRA-PSM With Synthetic Peptides E-PRA and E-PSM in Subjects With Advance Solid Malignancies

The majority of tumors are ignored by the immune system and it was thought for a long time
that tumor antigens did not exist. However, recently a number of tumor antigens have been
described. These antigens reside on cancer cells and can be recognized by specific T-cells
which can ultimately attack and destroy the tumor.

Inclusion Criteria:

18 years of age or older Advanced, refractory solid malignancy that is histologically
proven Measurable disease ECOG performance status of 0, 1 or 2 Adequate bone marrow
reserve as evidenced by a Absolute neutrophil count (ANC) = 1,500/microL; Platelet count =
100,000/microL Adequate renal and hepatic function as evidenced by a serum creatinine =
1.5 mg/dL; Serum total bilirubin = 2.0 mg/dL; Alkaline phosphatase = 3X the ULN for the
reference lab (= 5 the ULN for the reference lab for subjects with known hepatic
metastases); SGOT/SGPT = 3X the ULN for the reference lab (= 5 the ULN for the reference
lab for subjects with known hepatic metastases)

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